510(k) · Cleared
ClearedOpart (Including Opart Ultra and Ultra Gradient Upgrade Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 9, 2002 as substantially equivalent to K993574 (Toshiba America Mri, Inc., 2000) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Oct 9, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K903768 (1990). 19 ancestors in all, the oldest K900889 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
- 4 generations backK961092 VisartToshiba America Medical Systems, In.C · 1996 · Recalled
- 3 generations backK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
- 2 generations backK983110 Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc. · 1999
- 1 generation backK993574 Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
- This deviceK023207 Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903768 | Magnetic Resonance Device MRT 150A | Toshiba America Mri, Inc. | 1990 | — |
| −4 | K961092 | Visart | Toshiba America Medical Systems, In.C | 1996 | 5 |
| −3 | K965068 | Magnetic Resonanc Dvce Visart V 3.5 Software | Toshiba America Medical Systems, In.C | 1997 | — |
| −2 | K983110 | Flexart,Flexart/Hyper, Visart, Visart/Hyper | Toshiba America Mri, Inc. | 1999 | — |
| −1 | K993574 | Opart/Prodiga, Opart/Protenza, Opart/Paragon | Toshiba America Mri, Inc. | 2000 | — |
| 0 (this device) | K023207 | Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit) | Toshiba America Medical Systems, In.C | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993574 | Opart/Prodiga, Opart/Protenza, Opart/ParagonSummary page 1…available in each subsequent version (see Comparison Table, Appendix 7, for detailed description). A brief description follows: V4.0: V4.00 onto v3.0 (K993574) V4.1: V4.00 onto v3.1 (K993574) 1.2… | 2000 |
| * | K993803 | Excelart with PianissimoSummary page 3…is substantially equivalent to the Gradient System on EXCELARFMwith Pianissimo. The hardware configuration is substantially equivalent to model MRT-1501 /P2 system (K993803) cleared on February 4,2000 and the gradient performance such as the maximum slew rate and gradient strength is substantially… | 2000 |
| * | K002531 | Excelart with Pianissimo, Model MRT-1501/P3 | 2000 |
| * | — | EXCELART FM with Pianissimo Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 19 ancestors have a recall of any class.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
Imaging of
The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
Fluid Visualization
2D / 3D Imaging
MR Angiography / MR Vascular Imaging
Water / Fat Imaging
Perfusion / Diffusion Imaging
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023207: Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023207
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026